REDUCING ADENOVIRAL PATIENT-INFECTED DAYS (RAPID)

 描述(由申请人提供)：腺病毒结膜炎(Ad-Cs)是一种流行的疾病，占全科医生执业的2%，具有高度传染性，并具有相当大的经济影响。由于某些腺病毒血清型的流行潜力，Ad-Cs在德国和日本是一种可报告的情况。据估计，每年用于治疗急性结膜炎的费用为6.7亿美元，患者平均缺勤5天或缺课5天(2-10天不等)。将患者症状或传染性减少两三天的治疗将对公共卫生和经济产生重大影响。目前还没有FDA批准的治疗Ad-Cs的方法。治疗Ad-Cs的理想方法是安全、有效、低成本和可广泛获得。聚维酮碘(PVP-I)符合这些标准。PVP-I具有广谱抗菌效果和极好的安全性。“标签外”使用PVP-I治疗Ad-Cs已被视光和眼科社区内有影响力的社论和评论所推广。相当少数的临床医生报告使用PVP-I治疗Ad-Cs。不幸的是，PVP-I治疗Ad-Cs的研究一直没有得到控制，没有掩蔽和/或动力不足。随着PVP-I用于治疗Ad-Cs的非标签使用的增加，进行确凿研究的紧迫性增加了。一项权威研究的结果将影响 临床实践：PVP-I是否有效。缺乏效果将使数十万人免于无效的治疗。无论哪一种结果，都将为决定此类治疗是否应纳入医疗保险计划提供合理的基础。我们的长期目标是进行一项确定的随机临床试验，评估在办公室内使用5%PVP-I在减少病毒负荷和改善Ad-Cs患者症状方面是否比使用人工泪液的标准护理更有效。这项名为“减少腺病毒患者感染天数”(RAPID)的计划研究的具体目的是为一项全国性的多地点临床试验提供关键的计划参数，以明确地检验这一假设。

 DESCRIPTION (provided by applicant): Adenoviral conjunctivitis (Ad-Cs) is a prevalent condition comprising as much as 2% of a general practitioner's practice, is highly contagious, and has considerable economic impact. Because of the epidemic potential of some adenoviral serotypes, Ad-Cs is a reportable condition in Germany and Japan. An estimated $670 million is spent annually on the management of acute conjunctivitis, and afflicted patients miss on average five days of work or school (range 2-10). A treatment that reduces patient symptoms or contagion by even two or three days would have significant public health and economic impact. There are no FDA-approved treatments for Ad-Cs. The ideal treatment for Ad-Cs would be safe, effective, low- cost and widely accessible. Povidone iodine (PVP-I) meets these criteria. PVP-I has broad- spectrum antimicrobial effectiveness and an excellent safety profile. "Off-label" use of PVP-I to treat Ad-Cs has been promoted by influential editorials and reviews within the optometric and ophthalmological communities. A significant minority of clinicians report using PVP-I to treat Ad- Cs. Unfortunately, studies of PVP-I for the treatment of Ad-Cs have been uncontrolled, unmasked and/or underpowered. The urgency for a definitive study has increased with the growing off-label use of PVP-I to treat Ad-Cs. Results from a definitive study will affect clinical practice whether PVP-I is found effective or not. Absence of effect would spare hundreds of thousands from ineffective treatment. Either result would provide a rational basis for deciding whether such treatment should be covered in health insurance plans. Our long-term goal is to conduct a definitive, randomized clinical trial that evaluates whether or not a single, in-office application of 5% PVP-I is more effective than standard care with artificial tears at reducing vira load and improving symptoms in patients with Ad-Cs. The specific aims of this planning study "Reducing Adenoviral Patient-Infected Days" (RAPID) is to provide key planning parameters for a national, multi-site clinical trial to test this hypothesis definitively.